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Director, Process Analytical Technologies - Boston Massachusetts
Company: Vertex Pharmaceuticals Location: Boston, Massachusetts
Posted On: 05/01/2024
Director, Process Analytical Technologies page is loaded Director, Process Analytical Technologies Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-21473 Job DescriptionThe Director of PAT has central responsibility for global, virtual manufacturingoperations in a technical area, overseeing activities of staff and adapting personnel deployment to changing priorities. The Director champions continuous improvement of activities and relationships within and outside Vertex. The Director takes a leadership role in company-wide initiatives and guides resolution of critical issues impacting manufacturing operations.KEY RESPONSIBILITIES: - Spectroscopic method validation/implementation/revalidation and model maintenance (in house and working with CMO/CRO)
- Spectroscopic method development (NIR, Mid-IR, Raman, laser diffraction, acoustics)
- Experimental design to support new product commercialization and root cause analysis for existing products
- On-going support of commercial manufacturing activities utilizing continuous manufacturing processes and real-time release testing
- Data collection, multivariate data analysis for spectroscopy/process data, data interpretation, trending, and report generation
- Method transfers to new CMOs and analytical support for second-source activities
- Supporting new product development and commercialization and problem-solving/root cause analysis
- Authoring, reviewing, and approving technical documentation, including reports, protocols, work instructions, SOPs, etc.
- Understanding of physical characterization method development (XRPD, laser diffraction, vision analysis, powder flow analysis, etc.)
- Assist with troubleshooting pharmaceutical manufacturing operations and online PAT measurements in commercial manufacturing
- Assist with and lead resolution of quality investigations
- Work with supervisor to develop tools and standards for department functions
- Ensure positive and effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resources
- Independently represent Tech Ops on cross-functional CMC sub-teams
- Responsible for overall relationship with contract manufacturing partners; provides leadership for the working team
- Drive best practices for trend analysis and continuous process improvement
- Determine project assignments and staffing requirements for projects
- Assist in setting overall strategy for technical area and creation of department goals
- Takes full responsibility within scope of the position to work with groups such as Quality, Supply Ops, Regulatory, Pharm Dev, suppliers, etc. to proactively resolve issues that may negatively impact project timelines or deliverablesTECHNICAL AND COMMUNICATION SKILLS:
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